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Leukemia - Healing Genes
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Leukemia

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Cellular Immunotherapy in Treating Patients With High-Risk Acute Lymphoblastic Leukemia

Phase I Study to Evaluate Cellular Immunotherapy Using Memory-Enriched T Cells Lentivirally Transduced to Express a CD19-Specific, Hinge-Optimized, CD28-Costimulatory Chimeric Receptor and a Truncated EGFR Following Lymphodepleting Chemotherapy in Adult Patients With High-Risk CD19+ Acute Lymphoblastic Leukemia


Phase 1

DESCRIPTION:

Doctors at the City of Hope Medical Center are recruiting participants with acute lymphoblastic leukemia (ALL) that has recurred or persisted, for an investigatory gene-modified immunotherapy. Through gene editing outside the body, the patient’s own (autologous) immune T-cells will be programmed to attack their leukemia.

Researchers use a virus to insert a gene into the patient’s T-cells, which equips the cells to target their cancer. The treatment will require apheresis (drawing the blood to extract the T-calls) then, after they are gene-modified in the lab over several weeks, a course of chemotherapy will be required prior to an infusion of the cells. One infusion will be required and 2 may be provided, within a 28-day period, Follow up will occur at 12 months and for a total of 15 years.


PATIENT MUST:

  • Be 18 years of age or older
  • Meet cancer screening to ensure their leukemia meets study criteria
  • Not be pregnant or breastfeeding, be willing to take birth control

THE STUDY INVOLVES:

  1. Prescreening tests to confirm eligibility of the patient to participate.
  2. Blood will be drawn from the patient and genetically engineered in the lab.
  3. A course of chemotherapy is administered to reduce the patient’s existing bone marrow, giving room for the new cells to grow.
  4. A single infusion of the engineered cells will be given, and the patient’s reaction observed. After 28 days, an optional second dose may be given.
  5. After treatment, blood lab tests and follow up will be required at regular intervals to check the patient’s disease response.

LOCATIONS AND CONTACTS:

The study site is at the City of Hope Medical Center in Duarte, California. Map.

Samer K. Khaled  |  626-256-4673  |  [email protected]

 

SPONSOR INFORMATION:

The National Cancer Institute (NCI)

City of Hope Medical Center

 

Or go online:

https://clinicaltrials.gov/ct2/show/NCT02146924

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